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- MiscellaneousMiscellaneous
- ESIPolymer, Natural-Absorbable Gelatin Material3Product Code
- EWDProtector, Hearing (Insert)UProduct Code
- EWEProtector, Hearing (Circumaural)UProduct Code
- LEZAids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)UProduct Code
- LFAAids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)UProduct Code
- LFBButton, Nasal SeptalUProduct Code
- LRAHearing Aid, TactileUProduct Code
- LXVApparatus, Vestibular AnalysisUProduct Code
- MCMImplant, Cochlear3Product Code
- MHEImplant, Auditory Brainstem3Product Code
- MJVDevice, Inflation, Middle EarUProduct Code
- MPVImplant, Hearing, Active, Middle Ear, Partially Implanted3Product Code
- MRKSystem, Imaging, Fluorescence3Product Code
- QNUTranscutaneous Electrical Nerve Stimulator For The Relief Of Congestion2Product Code
- OAAAid, Visual, For NauseaNProduct Code
- QLVField Generator Positioning Device1Product Code
- EPGStimulator, Transdermal3Product Code
- OAFImplant, Hearing, Active, Middle Ear, Totally Implanted3Product Code
- OAQElectronic Media, HyperacusisNProduct Code
- OWODrug-Eluting Sinus Stent3Product Code
- PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3Product Code
- QJATympanostomy Tube Delivery Product With Drug3Product Code
- QOOVentilator Tubing And AccessoriesNProduct Code
- QOPRespiratory Humidifier For Emergency UseNProduct Code
- QOSContinuous VentilatorNProduct Code
- QOTEmergency VentilatorNProduct Code
- QOVCritical Care VentilatorNProduct Code
- QOXMulti-Patient Circuit ConnectorNProduct Code
- QQGOropharyngeal Electrical Stimulator2Product Code
- QVNCombined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus2Product Code
- QXGCooperative Powered Surgical Assist Device For Ent Surgery2Product Code
- QZCExternal Mechanical Stimulator For The Relief Of Congestion2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
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- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
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Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
- Page Type
- Product Code
- Definition
- Intended to provide electric stimulation to the mid to high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity.
- Physical State
- external sound processor, implant (w/ receiver/stimulator and electrode array), programming software, accessories
- Technical Method
- provide electric stimulation to the mid- to high frequency region of the cochlea via implant and acoustic amplification to the low frequency regions via an external component
- Target Area
- Head: Ear and Cochlea
- Review Panel
- Ear, Nose, Throat
- Submission Type
- PMA
- Device Classification
- Class 3
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- Yes
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
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No Linked CFR Text
The FDA has not linked product code PGQ to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.